Clearance Summary
THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM, MODEL 06-165-ZZZZ received FDA 510(k) clearance under submission number K033384, sponsored by Implex Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2003-11-19.
- Submission: K033384
- Applicant / Sponsor: Implex Corp.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3300
- Decision date: 2003-11-19
Classification & Regulation
This clearance is catalogued under FDA product code JDK and 21 CFR 878.3300, within the General, Plastic Surgery review panel as a Class II device.